The FDA has authorized drug imports from Canada to address high drug prices for the very first time.
The U.S. Food and Drug Administration (FDA) issued a decision Friday to allow Florida to import prescription medications from Canada as a way to provide access to cheaper drugs, marking the first time any state has received authorization for drug importation.
In a written statement, the FDA said the move "will significantly reduce the cost of covered products to the American consumer without posing additional risk to the public’s health and safety."
The authorization has been granted for a period of two years.
Florida Gov. Ron DeSantis introduced the plan in 2019, but it required FDA approval to move forward. In a statement, DeSantis said the approval will save Florida up to $180 million in the first year. The state will still be required to request approvals from the FDA for each specific drug before it is imported.
DeSantis said the state will begin by providing prescription drugs in a small number of drug classes, which will include maintenance medications to help individuals who have chronic health conditions such as HIV/AIDS, mental illness, prostate cancer, and urea cycle disorder.
These drugs will be for individuals who are under the care of the Agency for Persons with Disabilities (APD), Department of Children and Families (DCF), Department of Corrections (FDC), and Department of Health (DOH), according to the statement. The program will then expand to include providing imported prescription drugs for Medicaid members across the state.
The plan is backed by President Joe Biden, who signed an executive order in 2021 directing the FDA to work with states to enable drug imports.
However, the pharmaceutical industry’s trade organization said the importation of unapproved medicines "poses a serious danger to public health," promising to consider all options to prevent this policy from going ahead.
"We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan," the Pharmaceutical Research and Manufacturers of America said in a statement.
Canadian health officials have also expressed concerns that the plan could result in drug shortages in Canada. Health Canada says it is reviewing the FDA decision and told drug sellers that they cannot export medications outside the country if "doing so could cause or worsen a drug shortage."
Canada’s pharmaceutical national lobby group, Innovative Medicines Canada, also issued a statement expressing concern about the plan.
David Renwick, Interim President of IMC, said in the statement, "The U.S. market is nearly 10 times bigger than Canada’s, and allowing drugs that were intended for Canadians to be exported to the U.S. would harm Canadian patients and disrupt our health-care system."
- U.S. Food and Drug Administration. Re: Letter of Authorization for Florida’s Section 804 Importation Program.
- Florida Governor Ron DeSantis. Florida Becomes First in the Nation to Have Canadian Drug Importation Program Approved by FDA.
- PhRMA. PhRMA Statement on FDA Authorizing Florida’s Importation Plan.
- Government of Canada. The Drug Establishment Licensing Bulletin.
- Innovative Medicines Canada. IMC statement on the FDA’s decision to allow Florida to import drugs from Canada.